MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a user facility report with the FDA on 2020-03-23 for V60 VENTILATOR 1053617 manufactured by Respironics California, Inc.
[187069225]
Date of event: (b)(6) 2020. Date of report: 23mar2020.
Patient Sequence No: 1, Text Type: N, H10
[187069226]
It was reported that the unit was not providing ventilation. The device was in use at the time of the event. The customer reported that the patient's saturation levels were a little low. The unit was swapped out for another ventilator and the patient's saturation levels returned to normal. The manufacturer's field service engineer (fse) performed troubleshooting and was unable to confirm the reported issue. The fse noted that the initial battery voltage was 16. 17. The fse checked the unit's significant event logs and there were no errors reported. The fse ran a full performance verification test on the unit and the unit passed. The unit was returned to the customer.
Patient Sequence No: 1, Text Type: D, B5
| Report Number | 2031642-2020-01000 |
| MDR Report Key | 9869186 |
| Report Source | USER FACILITY |
| Date Received | 2020-03-23 |
| Date of Report | 2020-03-12 |
| Date Mfgr Received | 2020-03-12 |
| Device Manufacturer Date | 2019-05-29 |
| Date Added to Maude | 2020-03-23 |
| Event Key | 0 |
| Report Source Code | Manufacturer report |
| Manufacturer Link | Y |
| Number of Patients in Event | 0 |
| Adverse Event Flag | 3 |
| Product Problem Flag | 3 |
| Reprocessed and Reused Flag | 3 |
| Reporter Occupation | OTHER HEALTH CARE PROFESSIONAL |
| Health Professional | 3 |
| Initial Report to FDA | 3 |
| Report to FDA | 3 |
| Event Location | 3 |
| Manufacturer Contact | MRS. MELISSA ABBOTT |
| Manufacturer Street | 2271 COSMOS COURT |
| Manufacturer City | CARLSBAD CA 92011 |
| Manufacturer Country | US |
| Manufacturer Postal | 92011 |
| Manufacturer Phone | 9093746996 |
| Manufacturer G1 | PHILIPS MEDICAL SYSTEMS |
| Manufacturer Street | 3000 MINUTEMAN ROAD |
| Manufacturer City | ANDOVER MA 01810 |
| Manufacturer Country | US |
| Manufacturer Postal Code | 01810 |
| Single Use | 3 |
| Previous Use Code | 3 |
| Event Type | 3 |
| Type of Report | 3 |
| Brand Name | V60 VENTILATOR |
| Generic Name | VENTILATOR, CONTINUOUS, MINIMAL VENTILATORY SUPPORT,FACILITY USE |
| Product Code | MNT |
| Date Received | 2020-03-23 |
| Model Number | V60 |
| Catalog Number | 1053617 |
| Operator | HEALTH PROFESSIONAL |
| Device Availability | Y |
| Device Eval'ed by Mfgr | Y |
| Device Sequence No | 1 |
| Device Event Key | 0 |
| Manufacturer | RESPIRONICS CALIFORNIA, INC |
| Manufacturer Address | 2271 COSMOS COURT CARLSBAD CA 92011 US 92011 |
| Patient Number | Treatment | Outcome | Date |
|---|---|---|---|
| 1 | 0 | 2020-03-23 |